Intraaortic ballon pump in cardiogenic shock II (IABP-SHOCK II Trial)

Cardiogenic shock is a fatal complication for patients with acute myocardial infarction (AMI) with a mortality of approximately 50%. Current treatment strategies are directed to revascularization of the infarct related artery by predominantly percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG). In addition to optimal fluids and medical support by catecholamines, support of the failing heart can be provided by special pumps in the aorta (named: intraaortic balloon pump). In this multicenter, randomized, clinical trial patients in cardiogenic shock complicating AMI are referred for revascularization of the infarct related artery. After checking in- and exclusion criteria computerized randomization is performed to either revascularization (preferred PCI) plus intraaortic balloon pump (IABP) insertion and optimal medical treatment or revascularization plus optimal medical treatment only. Intensive care treatment is performed according to standard care. The IABP will be weaned after hemodynamic stabilization, which is defined by sustained systolic blood pressure >90 mmHg without need for inotropic support. The hypothesis of this trial is that IABP support can reduce 30-day mortality, which is the primary outcome measure. The secondary outcome measures, such as hemodynamic, laboratory and clinical parameters, will serve as surrogate endpoints for prognosis of the patients. Furthermore, an intermediate and long-term follow-up at 6 and 12 months will be performed.